质量管理部门下设两个分支系统：质量控制监督系统和质量检验系统。
Quality management system has two branches: the quality of supervision and control system and quality inspection system.
监督实施质量管理体系。
药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.
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